Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GW597599 · 2 trials · 3 indications
| Arm | Type | Description |
|---|---|---|
| Active | EXPERIMENTAL | Vestipitant 15mg once daily |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| GW597599 | DRUG | GW597599 15mg tablet |
| Placebo | DRUG | Placebo to match GW597599 15mg tablet |
Inclusion Criteria: * Male and female aged 18-64 years inclusively with Diagnosis of Primary Insomnia according to Diagnostic and Statistical Manual of Mental Disorders -Text Revision (DSM-IV-TR) criteria 307.42 * PSG variables collected during 2consecutive PSG screening nights falling as follows: ...
GW597599 is an investigational small molecule being studied for the prevention of postoperative nausea and vomiting in female patients and for the treatment of sleep disorders. It has been evaluated in Phase 2 clinical trials for both indications, though it is not approved and remains in clinical development.
GW597599 is being developed by GSK plc, which trades under the ticker GSK. The company has sponsored clinical trials of the drug for postoperative nausea and vomiting and sleep disorders.
GW597599 is in Phase 2 clinical development. It has completed two Phase 2 trials, one for postoperative nausea and vomiting and one for sleep disorders. The drug is investigational and has not been approved by regulatory authorities.
GW597599 has been studied in two completed Phase 2 trials. NCT00600990 evaluated the drug for preventing postoperative nausea and vomiting in 624 female patients across multiple countries. NCT00992160 was a 28-day tolerance study in 161 participants with sleep disorders in Germany.
GW597599 is an NK-1 receptor antagonist, based on its classification as an anti-emetic medication targeting the neurokinin-1 receptor. This mechanism is relevant to its studied use in preventing postoperative nausea and vomiting.